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A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer

StatusRecruiting
PhasePhase 3
Started2024-11-22
View on ClinicalTrials.gov ↗

Amendment history

2026-02-24
Study Status, Contacts/Locations v4
Study sites88→208
2025-08-22
Study Status, Contacts/Locations v3
Study sites64→88
2025-05-27
Study Status, Contacts/Locations v2
Study sites47→64
2025-01-10
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11-01→confirmed 2024-11-22
Study sites1→47
Secondary endpoints3 entries, revised
Objective Response Rate (ORR) assessed by IRRC and investigator per RECIST v1.1 Adverse events (AE)
Primary endpoints2 entries, revised
Overall Survival （OS） Progression-Free Survival (PFS)per RECIST 1.1 assessed by IRRC(Independent Radiology Review Committee)
Collaborators+11 characters
Henlius USA
2024-07-31
Original filing
This is a double-blind, randomized, multiregion, comparative phase Ⅲ clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).
Trial Details
NCT Number NCT06532006
Lead Sponsor Shanghai Henlius Biotech
Collaborators: Henlius USA
Conditions Gastroesophageal-junction Cancer, Monoclonal Antibody, Gastric Cancer, HER2-positive Gastric Cancer
Enrollment 550 participants
Start Date 2024-11-22
Primary Completion 2027-06-01 (estimated)
Study Completion 2028-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-27